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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Posterior 10MHz B-scan Imaging of the Eye; 10MHz Biometric A-scan Imaging of the Eye; 8MHz Diagnostic A-scan Imaging of the Eye; Anterior 20MHz B-scan Imaging of the Eye.

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The provided text contains an FDA 510(k) clearance letter for the Ellex I SYSTEM-ABD Ver.4.0 (Eye Cubed V4) ultrasonic pulsed echo imaging system and its associated transducers. This document describes the intended use and classification of the device, confirming its substantial equivalence to a legally marketed predicate device.

However, the letter does not contain any information regarding specific acceptance criteria, clinical studies, device performance metrics, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt. The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, and the provided document is a notification of that clearance. It does not typically detail the specific testing and performance validation results that would be found in a comprehensive clinical study report.

Therefore, I cannot fulfill your request with the information provided. To generate the requested table and answer the study-specific questions, I would need a detailed clinical study report or a summary of performance data, which is not present in this 510(k) clearance letter.

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